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. 2019 Jun 7;2019(6):CD009593. doi: 10.1002/14651858.CD009593.pub4

Williamson 2012

Study characteristics
Patient sampling Cross‐sectional design, consecutive enrolment, prospective data collection
Patient characteristics and setting Presenting signs and symptoms: not reported: smear‐positive specimens
Age: 15 years and older
Sex, female: not reported
HIV infection: estimated < 1%
History of TB: not reported
Sample size: 89
Clinical setting: laboratory‐based
Laboratory level: central
Country: New Zealand
World Bank Income Classification: high income
High TB burden country: no
High MDR‐TB burden country: no
High TB/HIV burden country: no
TB incidence rate: 7.6 per 100,000
MDR‐TB prevalence: percentage MDR‐TB among new TB cases = 2.5% (Source: nationwide surveillance 2009) and among retreatment cases = 13% (Source: nationwide surveillance 2009)
Prevalence of TB cases in the study: 75.3%
Index tests Index: Xpert MTB/RIF
Target condition and reference standard(s) Target condition: pulmonary TB
Reference standard for pulmonary TB: MGIT 960
Target condition: rifampicin resistance
Reference standard for rifampicin resistance: MGIT 960
Flow and timing  
Comparative  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes
Was a case‐control design avoided? Yes
Did the study avoid inappropriate exclusions? No
High Unclear
DOMAIN 2: Index Test Xpert MTB/RIF
Were the index test results interpreted without knowledge of the results of the reference standard? Yes
If a threshold was used, was it pre‐specified? Yes
Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes
Were the reference standard results for TB detection interpreted without knowledge of the results of the index test? Yes
Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test? Yes
Low Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes
Did all patients receive the same reference standard? Yes
Were all patients included in the analysis? Yes
Low